COVID-19: Oncology clinical trials enrollment falls
medwireNews: The COVID-19 outbreak is associated with a decrease in accrual to cancer clinical trials, indicate US data.
As reported in JAMA Network Open, researcher Joseph Unger (Fred Hutchinson Cancer Research Center, Seattle, Washington, USA) and colleagues examined enrollment to trials conducted by the SWOG Cancer Research Network between January and April 2020.
On average, 137 participants were enrolled per week, from the first week of January to the second week of March, with numbers ranging from 125 to 150 per week. Accrual dropped to 109 participants in the third week of March and did not exceed 74 participants per week from the fourth week of March until the end of the study period.
The drop in enrollment was accompanied by a rise in COVID-19 cases, from 2918 in the second week of March to 25,697 in the third week and up to nearly a million by the end of April.
There were no significant differences in enrollment by age, race, or ethnicity, but women were “marginally less likely” than men to be recruited in the period from the third week of March to the end of April (odds ratio [OR]=0.77), says the team.
Cancer control and prevention trials had a significant drop in enrollment relative to treatment trials (OR=0.38), “potentially reflecting an emphasis on offering beneficial treatment to individual patients,” report Unger et al. Sites from states in the top quintile of COVID-19 cases per 100,000 residents also had a significant fall in enrollment.
The study authors caution that the study is limited by the inclusion of data from just one of the four adult US National Cancer Institute (NCI) network groups, but add that “the findings are consistent with observed systemwide decreases in accrual.”
They note that the NCI and FDA have responded by issuing “guidance to provide greater flexibility to ensure that patients enrolled in clinical trials are exposed to as little risk as possible during the COVID-19 pandemic.”
Unger and colleagues conclude: “Such measures are vitally important given the critical role government- and industry-sponsored trials play in establishing new oncology treatment options for patients.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group
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